Efficacy and Safety of Vildagliptin as add-on Therapy to Metformin in Patients With Type 2 Diabetes
A Multicenter, Double-Blind, Randomized, Parallel-Group Study to Compare the Effect of 12 Weeks Treatment With LAF237 50 mg Bid to Placebo as Add-On Therapy in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy
1 other identifier
interventional
183
1 country
20
Brief Summary
The purpose of the study is to evaluate the efficacy and safety of vildagliptin 50 mg bid as an add-on therapy to metformin in Japanese patients with T2DM. This study is being conducted to support registration of the fixed-dose combination of vildagliptin and metformin for the treatment of Type 2 diabetes mellitus (T2DM) in Japan.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 diabetes-mellitus-type-2
Started Dec 2011
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 20, 2011
CompletedFirst Posted
Study publicly available on registry
December 22, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedFebruary 27, 2017
February 1, 2017
1.2 years
December 20, 2011
February 23, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in glycosylated hemoglobin (HbA1c) at 12 weeks between treatment groups
HbA1c will be performed on a blood sample obtained by study personnel and measured by high-performance liquid chromatography (HPLC) performed at a central laboratory.
Baseline to 12 weeks
Secondary Outcomes (4)
Change from baseline in HbA1c at 12 weeks within subgroups of metformin doses
Baseline to 12 weeks
Change from baseline in Fasting plasma glucose (FPG) at 12 weeks
Baseline to 12 weeks
Percentage of patients meeting Responder rates in HbA1c
12 weeks
Number of patients with adverse events (including hypoglycemia), serious adverse events and death
12 weeks
Study Arms (2)
Vildagliptin
EXPERIMENTALIn addition to their stable dose of metformin monotherapy, patients should take vildagliptin 50 mg twice daily.
Placebo
PLACEBO COMPARATORIn addition to their stable dose of metformin monotherapy, patients should take vildagliptin matching placebo.
Interventions
Eligibility Criteria
You may qualify if:
- Patients with type 2 diabetes inadequately controlled with diet, exercise and oral anti-diabetic therapy.
- HbA1c in the range of 7.0-10.0%
- Body mass index in the range 20-35 kg/m2
You may not qualify if:
- Type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes
- Significant heart diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Novartis Investigative Site
Fukuoka, Fukuoka, 810-0001, Japan
Novartis Investigative Site
Fukuoka, Fukuoka, 819-0168, Japan
Novartis Investigative Site
Kitakyushu, Fukuoka, 800-0296, Japan
Novartis Investigative Site
Kurume, Fukuoka, 830-8543, Japan
Novartis Investigative Site
Ohkawa-city, Fukuoka, 831-0016, Japan
Novartis Investigative Site
Kawasaki, Kanagawa, 210-0014, Japan
Novartis Investigative Site
Yokohama, Kanagawa, 221-0802, Japan
Novartis Investigative Site
Kyoto, Kyoto, 607-8062, Japan
Novartis Investigative Site
Kyoto, Kyoto, 615-0035, Japan
Novartis Investigative Site
Takatsuki, Osaka, 569-1096, Japan
Novartis Investigative Site
Ageo, Saitama, 362-8588, Japan
Novartis Investigative Site
Bunkyo-ku, Tokyo, 113-0031, Japan
Novartis Investigative Site
Edogawa-ku, Tokyo, 134-0084, Japan
Novartis Investigative Site
Hachiōji, Tokyo, 192-0046, Japan
Novartis Investigative Site
Kiyose, Tokyo, 204-0021, Japan
Novartis Investigative Site
Minato-ku, Tokyo, 105-7390, Japan
Novartis Investigative Site
Minato-ku, Tokyo, 108-0075, Japan
Novartis Investigative Site
Nerima-ku, Tokyo, 177-0051, Japan
Novartis Investigative Site
Shinagawa-ku, Tokyo, 141-0032, Japan
Novartis Investigative Site
Toshima-ku, Tokyo, 171-0021, Japan
Related Publications (1)
Odawara M, Hamada I, Suzuki M. Efficacy and Safety of Vildagliptin as Add-on to Metformin in Japanese Patients with Type 2 Diabetes Mellitus. Diabetes Ther. 2014 Jun;5(1):169-81. doi: 10.1007/s13300-014-0059-x. Epub 2014 Mar 7.
PMID: 24604395RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2011
First Posted
December 22, 2011
Study Start
December 1, 2011
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
February 27, 2017
Record last verified: 2017-02